Study participants Children with documented cow's milk allergy were eligible for inclusion in this trial.

Interventions After a 7-day period of strict avoidance of cow's milk protein and other suspected food allergens, participants were tested
with an EH casein formula with demonstrated hypoallergenicity (control, EHF) and a formula of the same composition with LGG
added at 108 colony-forming units per gram powder (EHF-LGG) in randomised order in a double-blind placebo-controlled food challenge (DBPCFC).
After absence of adverse reactions in the DBPCFC, an open challenge was performed with EHF-LGG, followed by a 7-day home feeding
period with the same formula.

Main outcome measure Clinical assessment of any adverse reactions to ingestion of study formulae during the DBPCFC.

Results For all participants with confirmed cow's milk allergy (n=31), the DBPCFC and open challenge were classified as negative.

Conclusion The EH casein formula supplemented with LGG is hypoallergenic and can be recommended for infants and children allergic to
cow's milk who require an alternative to formulae containing intact cow's milk protein.

Contributors AM, YM and MOH helped design the study, assessed study participants and collected study data, interpreted data and reviewed
and revised the manuscript. CL interpreted data and reviewed and revised the manuscript. JLW and DMFS interpreted data and
drafted the manuscript. CLH prepared and interpreted data and reviewed the manuscript. All authors contributed to the intellectual
content and approved the final version.

Funding The study was funded by the study sponsor, Mead Johnson Nutrition (study number 3369-2). Mead Johnson Nutrition provided
logistical support during the trial. Employees of the sponsor worked with study investigators to prepare the protocol, summarise
the collected data and write the manuscript.

Competing interests AM, MOH and YM have received research support from Mead Johnson Nutrition. CHL is a former employee of Mead Johnson Nutrition.
JLW, CLH and DMFS work in the Department of Medical Affairs at Mead Johnson Nutrition.